HERPES SORES - arsenic trioxide, bryonia alba root, lytta vesicatoria, chelidonium majus, helianthemum canadense, conium maculatum flowering top, croton tiglium seed, solanum dulcamara top, graphite, potassium dichromate, lycopodium clavatum spore, daphne mezereum bark, strychnos nux-vomica seed, kerosene, pulsatilla vulgaris, ranunculus bulbosus, toxicodendron pubescens leaf, smilax regelii root, sepia officinalis juice, sulfur, thuja occidentalis leafy twig, echinacea, unspecified, hypericum perforatum, echinacea, unspecified and hypericum perforatum liquid 
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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PRODUCT NAME & INDICATIONS SECTION

HERPES SORES  Formulated for associated symptoms of Herpes Simplex and Herpes Zoster such as itching, tingling, crusting and painful skin eruptions or ulcerations.        

DIRECTION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.       

ACTIVE INGREDIENT SECTION

Arsenicum alb. 15x, Bryonia 15x, Cantharis 15x,  Chelidonium majus 15x, Cistus canadensis 15x, Conium 15x, Croton 15x, Dulcamara 15x, Graphites 15x, Kali bic. 15x, Lycopodium 15x, Mezereum 15x, Nux vom. 15x, Petroleum 15x, Pulsatilla 15x, Ranunc. bulb. 15x, Rhus toxicodendron 15x,  Sarsaparilla 15x, Sepia 15x, Sulphur 15x, Thuja occ. 15x, Echinacea 8x, Hypericum  8x, Echinacea 3x, Hypericum 3x.               

PURPOSE SECTION

Formulated for associated symptoms of Herpes Simplex and Herpes Zoster such as itching, tingling, crusting and painful skin eruptions or ulcerations.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.                 

QUESTIONS? SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256                

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.                        

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.          

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.               

PACKAGE LABEL.

Package Label

HERPES SORES  
arsenicum alb., bryonia,cantharis, chelidonium majus, cistus canadensis, conium, croton, dulcamara,graphites, kali bic., lycopodium, mezereum, nux vom., petroleum, pulsatilla, ranunc. bulb., rhus toxicodendron, sarsaparilla, sepia, sulphur, thuja occ., echinacea, hypericum liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:55714-4452
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arsenic Trioxide (Arsenic Cation (3+)) Arsenic Trioxide15 [hp_X]  in 1 mL
Bryonia Alba Root (Bryonia Alba Root) Bryonia Alba Root15 [hp_X]  in 1 mL
Lytta Vesicatoria (Lytta Vesicatoria) Lytta Vesicatoria15 [hp_X]  in 1 mL
Chelidonium Majus (Chelidonium Majus) Chelidonium Majus15 [hp_X]  in 1 mL
Helianthemum Canadense (Helianthemum Canadense) Helianthemum Canadense15 [hp_X]  in 1 mL
Conium Maculatum Flowering Top (Conium Maculatum Flowering Top) Conium Maculatum Flowering Top15 [hp_X]  in 1 mL
Croton Tiglium Seed (Croton Tiglium Seed) Croton Tiglium Seed15 [hp_X]  in 1 mL
Solanum Dulcamara Top (Solanum Dulcamara Top) Solanum Dulcamara Top15 [hp_X]  in 1 mL
Graphite (Graphite) Graphite15 [hp_X]  in 1 mL
Potassium Dichromate (Dichromate Ion) Potassium Dichromate15 [hp_X]  in 1 mL
Lycopodium Clavatum Spore (Lycopodium Clavatum Spore) Lycopodium Clavatum Spore15 [hp_X]  in 1 mL
Daphne Mezereum Bark (Daphne Mezereum Bark) Daphne Mezereum Bark15 [hp_X]  in 1 mL
Strychnos Nux-vomica Seed (Strychnos Nux-vomica Seed) Strychnos Nux-vomica Seed15 [hp_X]  in 1 mL
Kerosene (Kerosene) Kerosene15 [hp_X]  in 1 mL
Pulsatilla Vulgaris (Pulsatilla Vulgaris) Pulsatilla Vulgaris15 [hp_X]  in 1 mL
Ranunculus Bulbosus (Ranunculus Bulbosus) Ranunculus Bulbosus15 [hp_X]  in 1 mL
Toxicodendron Pubescens Leaf (Toxicodendron Pubescens Leaf) Toxicodendron Pubescens Leaf15 [hp_X]  in 1 mL
Smilax Regelii Root (Smilax Regelii Root) Smilax Regelii Root15 [hp_X]  in 1 mL
Sepia Officinalis Juice (Sepia Officinalis Juice) Sepia Officinalis Juice15 [hp_X]  in 1 mL
Sulfur (Sulfur) Sulfur15 [hp_M]  in 1 mL
Thuja Occidentalis Leafy Twig (Thuja Occidentalis Leafy Twig) Thuja Occidentalis Leafy Twig15 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified8 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum8 [hp_X]  in 1 mL
Echinacea, Unspecified (Echinacea, Unspecified) Echinacea, Unspecified3 [hp_X]  in 1 mL
Hypericum Perforatum (Hypericum Perforatum) Hypericum Perforatum3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Packaging
#Item CodePackage Description
1NDC:55714-4452-129.57 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/01/2011
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-4452), API MANUFACTURE(55714-4452)

Revised: 06/2011
Document Id: f532bb97-b5e0-8d36-5418-269d93b7d059
Set id: 7debaeec-50fc-a03b-dbab-83a6770f9aa7
Version: 1
Effective Time: 20110601
 
Newton Laboratories, Inc.